Ticlopidine Hydrochloride

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Side Effects & Adverse Reactions

Hematological Adverse Reactions

NEUTROPENIA

Neutropenia may occur suddenly. Bone-marrow examination typically shows a reduction in white blood cell precursors. After withdrawal of ticlopidine, the neutrophil count usually rises to > 1200/mm3 within 1 to 3 weeks.

THROMBOCYTOPENIA

Rarely, thrombocytopenia may occur in isolation or together with neutropenia.

THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP)

TTP is characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes [fragmented RBCs] seen on peripheral smear), neurological findings, renal dysfunction, and fever. The signs and symptoms can occur in any order; in particular, clinical symptoms may precede laboratory findings by hours or days. With prompt treatment (often including plasmapheresis), 70% to 80% of patients will survive with minimal or no sequelae. Because platelet transfusions may accelerate thrombosis in patients with TTP on ticlopidine, they should, if possible, be avoided.

APLASTIC ANEMIA

Aplastic anemia is characterized by anemia, thrombocytopenia and neutropenia together with a bone marrow examination that shows decreases in the precursor cells for red blood cells, white blood cells, and platelets. Patients may present with signs or symptoms suggestive of infection, in association with low white blood cell and platelet counts. Prompt treatment, which may include the use of drugs to stimulate the bone marrow, can minimize the mortality associated with aplastic anemia.

MONITORING FOR HEMATOLOGIC ADVERSE REACTIONS

Starting just before initiating treatment and continuing through the third month of therapy, patients receiving ticlopidine hydrochloride must be monitored every 2 weeks. Because of ticlopidine’s long plasma half-life, patients who discontinue ticlopidine during this 3-month period should continue to be monitored for 2 weeks after discontinuation. More frequent monitoring, and monitoring after the first 3 months of therapy, is necessary only in patients with clinical signs (e.g., signs or symptoms suggestive of infection) or laboratory signs (e.g., neutrophil count less than 70% of the baseline count, decrease in hematocrit or platelet count) that suggest incipient hematological adverse reactions.

Clinically, fever might suggest neutropenia, TTP or aplastic anemia; TTP might also be suggested by weakness, pallor, petechiae or purpura, dark urine (due to blood, bile pigments, or hemoglobin) or jaundice, or neurological changes. Patients should be told to discontinue ticlopidine hydrochloride and to contact the physician immediately upon the occurrence of any of these findings. Laboratory monitoring should include a complete blood count, with special attention to the absolute neutrophil count (WBC x % neutrophils), platelet count, and the appearance of the peripheral smear. Ticlopidine is occasionally associated with thrombocytopenia unrelated to TTP or aplastic anemia. Any acute, unexplained reduction in hemoglobin or platelet count should prompt further investigation for a diagnosis of TTP, and the appearance of schistocytes (fragmented RBCs) on the smear should be treated as presumptive evidence of TTP. A simultaneous decrease in platelet count and WBC count should prompt further investigation for a diagnosis of aplastic anemia. If there are laboratory signs of TTP or aplastic anemia, or if the neutrophil count is confirmed to be < 1200/mm3, then ticlopidine hydrochloride should be discontinued immediately.

Other Hematological Effects

Rare cases of agranulocytosis, pancytopenia or leukemia have been reported in postmarketing experience, some of which have been fatal. All forms of hematological adverse reactions are potentially fatal.

Cholesterol Elevation

Ticlopidine hydrochloride therapy causes increased serum cholesterol and triglycerides. Serum total cholesterol levels are increased 8% to 10% within 1 month of therapy and persist at that level. The ratios of the lipoprotein subfractions are unchanged.

Anticoagulant Drugs

The tolerance and safety of coadministration of ticlopidine hydrochloride with heparin, oral anticoagulants, or fibrinolytic agents have not been established. If a patient is switched from an anticoagulant or fibrinolytic drug to ticlopidine hydrochloride, the former drug should be discontinued prior to ticlopidine hydrochloride administration.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Ticlopidine hydrochloride tablets are indicated:

to reduce the risk of thrombotic stroke (fatal or nonfatal) in patients who have experienced stroke precursors, and in patients who have had a completed thrombotic stroke. Because ticlopidine hydrochloride is associated with a risk of life-threatening blood dyscrasias including thrombotic thrombocytopenic purpura (TTP), neutropenia/agranulocytosis and aplastic anemia (see BOXED WARNING and WARNINGS), ticlopidine hydrochloride should be reserved for patients who are intolerant or allergic to aspirin therapy or who have failed aspirin therapy.
as adjunctive therapy with aspirin to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation (see CLINICAL TRIALS).

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History

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Other Information

Ticlopidine hydrochloride is a platelet aggregation inhibitor. Chemically it is 5-[(2-chlorophenyl)methyl]-4,5,6,7-tetrahydrothieno [3,2-c] pyridine hydrochloride. The structural formula is:

Ticlopidine hydrochloride is a white crystalline solid. It is freely soluble in water and self buffers to a pH of 3.6. It also dissolves freely in methanol, is sparingly soluble in methylene chloride and ethanol, slightly soluble in acetone, and insoluble in a buffer solution of pH 6.3. It has a molecular weight of 300.25.

Each tablet, for oral administration, contains 250 mg of ticlopidine hydrochloride. In addition, each tablet contains the following inactive ingredients: ammonium chloride, magnesium stearate, microcrystalline cellulose, povidone, starch (corn), and stearic acid. The white film coating contains hydroxypropylmethyl cellulose, lactose monohydrate, titanium dioxide and triacetin.

Sources

Ticlopidine Hydrochloride Manufacturers

Genpharm

Ticlopidine Hydrochloride | Genpharm

Stroke
The recommended dose of ticlopidine hydrochloride tablets is 250 mg bid taken with food. Other doses have not been studied in controlled trials for these indications.
Coronary Artery Stenting
The recommended dose of ticlopidine hydrochloride tablets is 250 mg bid taken with food together with antiplatelet doses of aspirin for up to 30 days of therapy following successful stent implantation.

No Recall
Eon Labs, Inc.

Ticlopidine Hydrochloride | Eon Labs, Inc.

Stroke
The recommended dose of ticlopidine hydrochloride is 250 mg bid taken with food. Other doses have not been studied in controlled trials for these indications.
Coronary Artery Stenting
The recommended dose of ticlopidine is 250 mg bid taken with food together with antiplatelet doses of aspirin for up to 30 days of therapy following successful stent implantation.

No Recall
Apotex Corp.

Ticlopidine Hydrochloride | Apotex Corp.

Stroke
The recommended dose of ticlopidine hydrochloride is 250 mg bid taken with food. Other doses have not been studied in controlled trials for these indications.
Coronary Artery Stenting
The recommended dose of ticlopidine hydrochloride is 250 mg bid taken with food together with antiplatelet doses of aspirin for up to 30 days of therapy following successful stent implantation.

No Recall
Teva Pharmaceuticals Usa Inc

Ticlopidine Hydrochloride | Teva Pharmaceuticals Usa Inc

Stroke
The recommended dose of ticlopidine hydrochloride is 250 mg bid taken with food. Other doses have not been studied in controlled trials for these indications.
Coronary Artery Stenting
The recommended dose of ticlopidine hydrochloride is 250 mg bid taken with food together with antiplatelet doses of aspirin for up to 30 days of therapy following successful stent implantation.

No Recall
Caraco Pharmaceutical Laboratories, Ltd.

Ticlopidine Hydrochloride | Caraco Pharmaceutical Laboratories, Ltd.

Stroke: The recommended dose of ticlopidine hydrochloride is 250 mg bid taken with food. Other doses have not been studied in controlled trials for these indications.

Coronary Artery Stenting: The recommended dose of ticlopidine hydrochloride is 250 mg bid taken with food together with antiplatelet doses of aspirin for up to 30 days of therapy following successful stent implantation.

No Recall
Avkare, Inc.

Ticlopidine Hydrochloride | Avkare, Inc.

Stroke
The recommended dose of ticlopidine hydrochloride is 250 mg bid taken with food. Other doses have not been studied in controlled trials for these indications.
Coronary Artery Stenting
The recommended dose of ticlopidine hydrochloride is 250 mg bid taken with food together with antiplatelet doses of aspirin for up to 30 days of therapy following successful stent implantation.

No Recall
Carilion Materials Management

Ticlopidine Hydrochloride | Carilion Materials Management

Stroke
The recommended dose of ticlopidine hydrochloride is 250 mg bid taken with food. Other doses have not been studied in controlled trials for these indications.
Coronary Artery Stenting
The recommended dose of ticlopidine hydrochloride is 250 mg bid taken with food together with antiplatelet doses of aspirin for up to 30 days of therapy following successful stent implantation.

No Recall